Efficacy of Non-ablative Radiofrequency Combined With Pelvic Floor Muscle Training for Genitourinary Syndrome of Menopause in Breast Cancer Survivors (RF-SGM)

The goal of this clinical trial is to find out whether non-ablative radiofrequency (RF) applied together with pelvic-floor muscle exercises can ease vaginal dryness and other symptoms of genitourinary syndrome of menopause (GSM) in women aged 18-75 years who have survived breast cancer and currently experience those symptoms. The main questions it aims to answer are: Does the combination of RF + exercise lower the 0-to-10 vaginal-dryness score more than sham (inactive) RF + exercise at 6 weeks (end of treatment) and 3 months? What other changes (pain during intercourse, Vaginal Health Index

Trial Details

NCT ID
NCT07034976
Phase
NA
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • Active Radiofrequency (Capenergy C500 UpGradeC200)
  • Sham Radiofrequency (Capenergy C500 UpGrade C200 - Placebo Mode)
Locations (sample)
  • Madrid, Madrid, Spain|40.4165,-3.70256

Key Eligibility Criteria

  • Women who are breast cancer survivors and clinically confirmed to be disease-free by their physician.
  • Amenorrhea for more than 12 months and vaginal pH ≥ 5, with symptoms related to genitourinary syndrome of menopause (GSM), as diagnosed by a physic…
  • Negative urine culture at baseline.
  • Moderate to severe vaginal dryness, defined as a score \> 4 on the Numeric Rating Scale (NRS 0-10)

For full eligibility, visit ClinicalTrials.gov.

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